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Immunointervention With Calcitriol in New-Onset Type 1 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00960635
First Posted: August 18, 2009
Last Update Posted: August 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Institut fur Diabetesforschung, Munich, Germany
  Purpose
This is a randomized, two-arm, placebo-controlled phase-2 trial to determine whether the daily intake of 1,25-dihydroxy-vitamin D3 [1,25(OH)2D3], improves beta cell function in patients with recently diagnosed type 1 diabetes. The treatment consists of the daily oral administration of 0.25 µg 1,25(OH)2D3 or placebo for 9 months and an equal follow-up time without supplementation. Fasting, peak and AUC C-peptide concentrations during a 2-hour mixed meal tolerance test are measured at the beginning of the study, as well as at the end of the treatment and the follow-up period in month 9 and 18. The null hypothesis is that there is no difference between 1,25(OH)2D3 treated subjects and the placebo group in the AUC C-peptide at month 18.

Condition Intervention Phase
Type 1 Diabetes Drug: 1,25-dihydroxy-vitamin D3 (calcitriol) Drug: placebo Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Prevention
Official Title: Immunointervention With 1,25-dihydroxy-vitamin D3 in New-onset Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Institut fur Diabetesforschung, Munich, Germany:

Study Start Date: June 2001
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: calcitriol Drug: 1,25-dihydroxy-vitamin D3 (calcitriol)
Placebo Comparator: pill without agent Drug: placebo
pill without agent

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • New onset Typ 1 diabetes (< 6 weeks insulin therapy)
  • Age 18-39 years
  • GADA and/or IA-2A positive

Exclusion Criteria:

  • Kidney disease
  • Pregnancy
  • Lactating
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00960635


Locations
Germany
Institut fuer Diabetesforschung
Munich, Germany, 80804
Sponsors and Collaborators
Institut fur Diabetesforschung, Munich, Germany
Investigators
Principal Investigator: Anette G Ziegler, MD Institut fuer Diabetesforschung
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anette Ziegler, MD, Institut fuer Diabetesforschung
ClinicalTrials.gov Identifier: NCT00960635     History of Changes
Other Study ID Numbers: 336/00
First Submitted: August 17, 2009
First Posted: August 18, 2009
Last Update Posted: August 18, 2009
Last Verified: August 2009

Keywords provided by Institut fur Diabetesforschung, Munich, Germany:
new-onset

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Calcitriol
Dihydroxycholecalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents